BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 7132042 · Received December 19, 2017

    Report

    Report Number
    6000034-2017-02259
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    December 20, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON DECEMBER 20, 2017.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PMA/510(K) NUMBER IS K131240.

    Description of Event or Problem · 1

    PER THE CLINIC, IT WAS REPORTED THAT PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE FOLLOWING AN MRI (TESLA UNKNOWN); SUBSEQUENTLY THE PATIENT UNDERWENT REVISION SURGERY (DATE NOT REPORTED) TO REMOVE THE INTERNAL MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910770 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention